NCT06425549Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
A Multicenter, Randomized, Parallel-Group, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to \<18 years of age with moderate to severe plaque psoriasis (PSO).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 176 (actual)
- First submitted
- 2 May 2024
- Start date
- Jun 2024
- Primary completion date
- Aug 2028
- Lead sponsor
- UCB Biopharma SRL
- Diseases
- Psoriasis
- NCT number
- NCT06425549
- EU CT number
- 2023-503859-10-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 176
- From Jun 2024 to the primary completion date, Aug 2028
- 48 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Study participant has previously received bimekizumab
- Study participant has previously received ustekinumab
- Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments
- Study participant diagnosed with severe depression in the past 6 months (prior to Screening) should be excluded
Other illness
- Primary failure (no response within 12 weeks) to 1 or more interleukin-17 (IL-17) biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier other than an IL-17
- Study participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO
- Study participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD
- History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated
- Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)
- Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study
Other
- Study participant has the presence of active suicidal ideation, or positive suicide behavior
Who the study is looking for
- Study participant must be 6 to \<18 years of age, inclusive, at the time of signing the informed consent/assent according to local regulation
- Study participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit
- Study participant meets the following at both the Screening and Baseline Visits:
- Body surface area (BSA) affected by PSO ≥10%
- . Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)
- . Psoriasis Area and Severity Index (PASI) score ≥12 OR
- PASI score ≥10 plus at least 1 of the following:
- Clinically relevant facial involvement ii) Clinically relevant genital involvement iii) Clinically relevant hand and foot involvement
- Study participant is a candidate for systemic PSO therapy and/or photo/chemotherapy and for treatment with ustekinumab per labeling
- Study participant has body weight ≥15 kg and body mass index for age percentile of ≥5 at Screening
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (48)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Active, not recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Active, not recruiting |
| Ps0021 50618 Coordinator of this site? Confirm its status | Mississauga | Canada | Unknown status |
| Ps0021 50357 Coordinator of this site? Confirm its status | St. John's | Canada | Unknown status |
| Fakultni Nemocnice Plzen Coordinator of this site? Confirm its status | Plzen 3 | Czechia | Active, not recruiting |
| Thermalsole und Schwefelbad Bentheim GmbH Coordinator of this site? Confirm its status | Bad Bentheim | Germany | Active, not recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Active, not recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Active, not recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Active, not recruiting |
| Katholisches Kinderkrankenhaus Wilhelmstift gGmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Active, not recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Active, not recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Active, not recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Sant Joan De Deu Barcelona Hospital Coordinator of this site? Confirm its status | Esplugues De Llobregat | Spain | Active, not recruiting |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| Centre Hospitalier Victor Dupouy Coordinator of this site? Confirm its status | Argenteuil Cedex | France | Completed |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Completed |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Active, not recruiting |
| Somogy Vármegyei Kaposi Mór Oktató Kórház Coordinator of this site? Confirm its status | Kaposvár | Hungary | Active, not recruiting |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Active, not recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Ps0021 20071 Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| Ps0021 20033 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Ps0021 20337 Coordinator of this site? Confirm its status | Shimotsuga-gun | Japan | Unknown status |
| Renew Clinic Sp. z o.o. Coordinator of this site? Confirm its status | Bialystok | Poland | Active, not recruiting |
| Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| DERMED Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Nowa Sol | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie Coordinator of this site? Confirm its status | Rzeszów | Poland | Active, not recruiting |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. Coordinator of this site? Confirm its status | Szczecin | Poland | Active, not recruiting |
| dermMedica Sp. z o.o Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Ps0021 50201 Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Ps0021 50084 Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Ps0021 50355 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Ps0021 50162 Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| Ps0021 50344 Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Ps0021 50161 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Ps0021 50196 Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.